Passing US FDA site inspections is vital to attracting international clients, a European API supplier has said.

Even among clients outside the US, approval by the US Food and Drug Administration (FDA) is an important endorsement, according to ChemCon, a German company which develops and manufactures custom active pharmaceutical ingredients (APIs) as well as performing contract R&D.

FDA inspections are “relevant for an awful lot of our customers because they represent one of the best signs of quality,” Owen Pryce, Sales Manager, ChemCon, told in-PharmaTechnologist.com.

According to a budget request
for the new fiscal year, FDA inspections outside the USA are planned to increase
at a far greater rate than domestically, numbering 999 in 2015.

Fourth inspection

ChemCon passed an FDA inspection of its main site in Freiburg, Germany, it announced this week. The review of GMP compliance examined quality assurance systems relating to the production of APIs for a US market, said Pryce.

Such visits include checks on equipment, manufacturing facilities, materials and quality controls and can result in the FDA issuing a Form 483
to failing sites.

In ChemCon’s case, an “NAI” (no action indicated) classification was given to the plant, which has four clean rooms. This is its fourth FDA inspection since it was built 17 years ago.

Custom API supply

ChemCon’s API customers are mostly European and North American, with other markets in the Middle East, Australia and Japan, Pryce told us.

The company specialises in small molecule organic and inorganic chemistry, creating custom APIs.

“If a customer wants a completely new API that’s not on the market, we can develop that and then we can upscale under GMP conditions,” said Pryce. The firm also supplies generic APIs already on the market.

Tobias Timtner, ChemCon spokesman, described the company's production of ingredients for commercial purposes, including highly potent APIs, as “small to medium scale,” from a few hundred grams up to several hundred kg per year, depending on the type of API.

Related products

Technical / white paper

27-Jan-2015 - The European Pharmacopeia (Ph Eur) is moving away from the historical thin layer chromatography technique for the determination of Ninhydrin-positive substances, to more specific and sensitive methods utilising Liquid Chromatography (LC) or Amino Acid Analysers. This paper will explore the...